Comparison of two dose escalation strategies of methotrexate in active rheumatoid arthritis: a multicentre, parallel group, randomised controlled trial.

Annals of the Rheumatic Diseases
Siddharth JainSanjay Jain

Abstract

There are no head-to-head trials of different dose escalation strategies of methotrexate (MTX) in RA. We compared the efficacy, safety and tolerability of 'usual' (5 mg every 4 weeks) versus 'fast' (5 mg every 2 weeks) escalation of oral MTX. This multicentre, open-label (assessor blinded) RCT included patients 18-55 years of age having active RA with disease duration <5 years, and not on DMARDs. Patients were randomized 1:1 into usual or fast escalation groups, both groups starting MTX at 15 mg/week till a maximum of 25 mg/week. Primary outcome was EULAR good response at 16 weeks, secondary outcomes were ΔDAS28 and adverse effects (AE). Analyses were intention-to-treat. 178 patients with mean DAS28-CRP of 5.4(1.1) were randomized to usual (n=89) or fast escalation groups (n=89). At 16 weeks, there was no difference in good EULAR response in the usual (28.1%) or fast escalation (22.5%) groups (p=0.8). There was no difference in mean ΔDAS28-CRP at 8 weeks (-0.9, -0.8, p=0.72) or 16 weeks (-1.3, -1.3, p=0.98). Even at 24 weeks (extended follow-up), responses were similar. There were no inter-group differences in ΔHAQ, or MTX-polyglutamates 1-3 levels at 8 or 16 weeks. Gastrointestinal AE were higher in the fast escalation group o...Continue Reading

References

Mar 21, 2007·Annals of Internal Medicine·Yvonne P M Goekoop-RuitermanBen A C Dijkmans
Nov 1, 2008·Arthritis and Rheumatism·Judith M DalrympleMurray L Barclay
Nov 10, 2009·Behavior Research Methods·Franz FaulAlbert-Georg Lang
Dec 8, 2009·Rheumatic Diseases Clinics of North America·Jaap Fransen, Piet L C M van Riel
Nov 5, 2014·Nature Reviews. Rheumatology·Rohini Handa
Nov 8, 2015·Arthritis & Rheumatology·Jasvinder A SinghTimothy McAlindon

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